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Brand Names: US

Brand Names: Canada

What is this drug used for?

What do I need to tell my doctor BEFORE I take this drug?

For all patients taking this drug:

If you have an allergy to darunavir, ritonavir, or any other part of this drug.

If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

If you have liver disease.

If you are not taking cobicistat or ritonavir.

If you are taking sildenafil to treat pulmonary arterial hypertension (PAH).

If you take colchicine and have kidney or liver problems.

If you are taking St. John’s wort. Do not take St. John’s wort with this drug. This drug may not work as well.

If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with this drug, like certain drugs that are used for high cholesterol, migraines, or mood problems. There are many drugs that must not be taken with this drug.

If you are breast-feeding. Do not breast-feed while you take this drug.

Children:

If your child is younger than 3 years of age. Do not give to a child younger than 3 years of age.

This is not a list of all drugs or health problems that interact with this drug.Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take this drug?

For all patients taking this drug:

Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.

This drug interacts with many other drugs. The chance of this drug’s side effects may be raised or how well this drug works may be lowered. The chance of the other drugs’ side effects may also be raised. This may include very bad, life-threatening, or deadly side effects. Check with your doctor and pharmacist to make sure that it is safe for you to take this drug with all of your other drugs (prescription or OTC, natural products, vitamins).

If you have high blood sugar (diabetes), talk with your doctor. This drug may raise blood sugar.

Check your blood sugar as you have been told by your doctor.

Some people with hemophilia have had times of more bleeding when taking drugs like this one. If you have hemophilia, talk with your doctor.

Have blood work checked as you have been told by the doctor. Talk with the doctor.

This drug is not a cure for HIV. Stay under the care of your doctor.

This drug does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors. Talk with your doctor.

This drug is taken with other drugs. Be sure you know about the warnings, benefits, and risks of these other drugs. Talk with the doctor if you have questions or concerns about any of the drugs.

Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking this drug.

Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.

Children:

If your child’s weight changes, talk with the doctor. The dose of this drug may need to be changed.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.

Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.

Very bad dizziness or passing out.

Very bad headache.

Feeling very tired or weak.

Change in body fat.

Muscle or joint pain.

A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

Very bad and sometimes deadly liver problems have happened with this drug. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

This drug may help the immune system work. If you have an infection that you did not know you had, it may show up when you take this drug. Tell your doctor right away if you notice any signs of infection like fever, sore throat, weakness, cough, or shortness of breath after you start this drug.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

Headache.

Loose stools (diarrhea).

Belly pain.

Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.You may report side effects to your national health agency.

How is this drug best taken?

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.

All products:

Take this drug with food.

Take this drug at the same time as cobicistat or ritonavir as you have been told.

Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.

It is important that you do not miss or skip a dose of this drug during treatment.

Do not take didanosine within 1 hour before or 2 hours after taking this drug.

Tablets:

If you have trouble swallowing, talk with your doctor.

Liquid (suspension):

Shake well before use.

Measure liquid doses carefully. Use the measuring device that comes with this drug.

What do I do if I miss a dose?

Take a missed dose as soon as you think about it.

If it is close to the time for your next dose, skip the missed dose and go back to your normal time.

Do not take 2 doses at the same time or extra doses.

If you are not sure what to do if you miss a dose, call your doctor.

How do I store and/or throw out this drug?

Tablets:

Store at room temperature.

Liquid (suspension):

Store at room temperature. Do not refrigerate or freeze.

Store in original container.

Protect from heat.

All products:

Store in a dry place. Do not store in a bathroom.

Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.

Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

General drug facts

If your symptoms or health problems do not get better or if they become worse, call your doctor.

Do not share your drugs with others and do not take anyone else’s drugs.

Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.

Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.

Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

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If you have any questions or concerns, contact a member of your healthcare team directly or call 212-639-2000 for help.

If you have any questions or concerns, talk with a member of your healthcare team. You can reach them Monday through Friday from 9:00 am to 5:00 pm at ____________________. After 5:00 pm, during the weekend, and on holidays, please call____________________. If there’s no number listed, or you’re not sure, call 212-639-2000.

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